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Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| URiSCAN 10 SGL strip | U774 | FDA UDI | Class I | Active |
| URiSCAN 1 Ketones strip | U151 | EUDAMEDFDA UDI | Class I | Active |
| URiSCAN 6 L strip | U251 | EUDAMEDFDA UDI | Class II | Active |
| URiSCAN 10 SGL strip | U391 | EUDAMEDFDA UDI | Class II | Active |
| OcculTech Fecal Occult Blood Rapid Test | IM706-100M | FDA UDI | Class II | Active |
| URiSCAN 10 ACR strip | U621 | FDA UDI | Class I | Active |
| UCARE 11 Stick | P411 | FDA UDI | Class I | Active |
| URiSCAN 1 Glucose strip | U191 | FDA UDI | Class II | Active |
| URiSCAN 2 GP strip | U201 | FDA UDI | Class II | Active |
| UCARE 11 Stick | P412 | FDA UDI | Class I | Active |
| URiSCAN 2 ACR strip | U643 | FDA UDI | Class I | Active |
| Uriscan Optima Ii Urine Analyzer | K050801 | FDA 510(k) | Class II | Active |
| URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | K182038 | FDA 510(k) | Class II | Active |
| Preg-Q Early Pregnancy Test | K023027 | FDA 510(k) | Class II | Active |
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